Quality Assurance Engineer – Medical Devices (CAPA/ECN)

565 Merit Medical Singapore Pte. Ltd. F.K.A Argon Critical Care Systems Singapore Pte. Ltd.; Singapore; Presencial; SGD 70.000 - 110.000; Jornada completa

Descripción de la vacante

Merit Medical Systems seeks a Quality Engineer to support regulatory compliance and product quality for our medical devices. You will perform engineering tasks, manage ECNs, review nonconformances, and participate in CAPA activities across product lines, ensuring continued suitability of the quality management system.

The role emphasizes risk management documentation, supplier quality audits, and adherence to 21 CFR 820, ISO 13485, and related standards, with a focus on manufacturing controls

Formación

• Education/experience equivalent to a Bachelor's in Quality Engineering or related field, or a Master's Degree.
• Strong interpersonal, organizational, and verbal and written communication skills; ability to work in a team.

Responsabilidades

• Perform routine engineering work applying standard techniques and criteria.
• Identify and update failure modes and implement changes; manage ECNs and control methods.
• Review nonconformance records, determine disposition, root cause, and CAPA needs.
• Ensure containment of nonconforming product to prevent unintended use.
• Maintain quality management system effectiveness via audits, data analysis, and policy/objectives.
• Participate in supplier evaluations and quality audits of suppliers.

Conocimientos

Interpersonal skills

Communication

Teamwork

Statistical methods

Lean manufacturing

Six Sigma

Regulatory knowledge

Educación

Bachelor's degree in Quality Engineering or related field

Herramientas

Oracle

Crystal Reports

Descripción del empleo

Merit Medical Systems seeks a Quality Engineer to support regulatory compliance and product quality for our medical devices. You will perform engineering tasks, manage ECNs, review nonconformances, and participate in CAPA activities across product lines, ensuring continued suitability of the quality management system.

The role emphasizes risk management documentation, supplier quality audits, and adherence to 21 CFR 820, ISO 13485, and related standards, with a focus on manufacturing controls